It’s official – the Canadian government has approved the changes to Canada’s pharmaceutical patent regime. On May 16, 2017, Bill C-30 (the act intended to implement CETA into Canadian law) received royal assent, the final stage of the legislative process.
Treaty/Act: CETA/Bill C-30 (An Act to implement the Comprehensive Economic and Trade Agreement between Canada and the European Union and its Member States and to provide for certain other measures)
Date: May 16, 2017 – Bill C-30 receives Royal Assent
What are the changes? As we reported, CETA and Bill C-30 provide key reforms to the Patent Act affecting the pharmaceutical industry, including:
- Patent term restoration (i.e., certificates of supplementary protection or CSPs) capped at a maximum of two years for eligible patents covering eligible products; and
- Replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full actions resulting in a final determination of patent infringement and validity. Equal access to effective appeal rights will also be provided.
When will the changes come into force? Section 138 of Bill C-30 provides that most of the act comes into force on a day to be fixed by order of the Governor in Council. Under CETA, Article 30.7 – “Entry into force and provisional application” – we anticipate that Canada may provisionally implement the changes as early as June 1, 2017. It is expected that CETA will enter into full force on July 1, 2017. The regulations accompanying these reforms are expected to be published shortly.
Are you CETA ready? Contact Norton Rose Fulbright with all your CETA questions.
Text of the final Comprehensive Economic and Trade Agreement